Rehabilitation and Quality of Life Assessment for Soft Tissue Sarcoma Treated With Radiotherapy and Surgery

NCT03916796 | Terminated DMC

• 1 other identifier: 201904042
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study with a feasibility lead-in evaluating the use of multimodal cancer rehabilitation in patients planning to undergo radiotherapy and surgical resection for extremity or superficial trunk soft tissue sarcoma (STS). At enrollment, patients will be assigned to either a pre-operative radiation or post-operative radiation cohort.

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• Percentage of prescribed dietary and physical therapy visits completed during the cancer rehabilitation protocol

  * This will be quantified as the proportion of prescribed visits within the prehabilitation protocol that are attended by the patient. If a patient participates in any portion of a prescribed visit, it will be counted as attended. * Physical therapy visits are optional from 6 months-24 months

  Through 3 month follow-up

Secondary Outcomes (10)

• Rate of acute treatment-related grade 2 or higher toxicity attributed to the therapy

  From baseline through 24 month follow-up

• Quality of life as measured by the PROMIS Global total score

  Change from baseline through 24 month follow-up

• Quality of life as measured by the TESS

  Change from baseline through 24 month follow-up

• Patient cardiovascular capacity as measured by the 6-minute walk test

  Change from baseline through 3 month follow-up

• Patient general physical health status as measured by 30-second sit to stand test

  Change from baseline through 3 month follow-up

Study Arms (2)

Pre-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel

EXPERIMENTAL

* Patients must be treated using daily image-guided radiotherapy * Dietary counseling at baseline * Exercise intervention throughout cancer rehabilitation protocol * Psychological screening with counselling services as needed - nurse will administer the NCCN distress thermometer and refer the patient to applicable psychological counselling

Other: Exercise; Other: Enhanced Recovery after surgery; Other: Psychological screening with counselling services as needed; Other: Dietary Counseling Services

Post-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel

EXPERIMENTAL

* Patients must be treated using daily image-guided radiotherapy * Dietary counseling at baseline * Exercise intervention throughout cancer rehabilitation protocol * Psychological screening with counselling services as needed - nurse will administer the NCCN distress thermometer and refer the patient to applicable psychological counselling

Other: Exercise; Other: Enhanced Recovery after surgery; Other: Psychological screening with counselling services as needed; Other: Dietary Counseling Services

Interventions

Exercise OTHER

-The exercise part will consist of an evaluation and treatment as prescribed by a physical therapist including aerobic \& dynamic stretching warm-up, strength training, balance training, and flexibility training. Will also include a home exercise program (HEP). Physical therapists will have specialized training in cancer rehabilitation obtained through the ReVital certification process.

Post-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel; Pre-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel

Enhanced Recovery after surgery OTHER

-The protocols include instructions for patient care from the time of pre-surgical admission to discharge, including directives regarding diet, labs, IV fluids, pain management, prophylactic medications, management of indwelling catheters and drains, and activity.

Also known as: ERAS

Post-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel; Pre-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel

Psychological screening with counselling services as needed OTHER

-The psychological screening will be completed by the Radiation Oncology nurse at the consult visit

Post-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel; Pre-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel

Dietary Counseling Services OTHER

-Patients will have a baseline nutrition counseling visit with a Registered Dietician. This may include a nutrition assessment and nutrition counseling to set priorities, establish goals, and create an individualized plan

Post-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel; Pre-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed soft tissue sarcoma of the extremity, or superficial trunk (abdomen or chest)
• Planning to receive radiotherapy and surgical resection
• At least 16 years of age.
• ECOG performance status ≤ 3
• Able to complete the cancer rehabilitation protocol safely, as determined by a treating physician.
• Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

You may not qualify if:

• Patients deemed ineligible for curative therapy by the treating medical oncologist, radiation oncologist, or surgeon.
• Patients with deep retroperitoneal or abdominal STS
• Patients who have received prior radiotherapy and, based on the treating radiation oncologist's opinion, may not safely be treated with protocol neoadjuvant radiotherapy.
• Currently receiving any investigational agents.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
• Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test prior to starting radiotherapy.
• HIV-positive patients whose CD4+ T-cell count is \< 350 cells/mcL.
• Receiving concurrent chemoradiation therapy

Sponsors & Collaborators

• Washington University School of Medicine: lead
• ReVital Cancer Rehabilitation: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Sarcoma

Interventions

Exercise; Enhanced Recovery After Surgery; Health Services Needs and Demand

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Perioperative Care; Surgical Procedures, Operative; Health Services Research; Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Matthew Spraker, M.D., Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 16, 2019
• Study Start: October 31, 2019
• Primary Completion: August 17, 2021
• Study Completion: March 18, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)